Recent results from Asterias’ SCISTar trials have the stem cell research community buzzing about promising new results in spinal cord function recovery with stem cell treatments.

Asterias’ SCISTar trial is focused on six recently paralyzed patients. Their severe spinal cord injuries were treated with injections of over 10 million oligodendrocytes progenitor cells. The number here is significant because Phase 1 of this trial garnered FDA clearance after using only 2 million cells.

The oligodendrocytes progenitor cells used in this trial are human embryonic stem cells that were isolated in 1998 from an embryo that was ethically donated to science. These oligodendrocytes support healthy regeneration of myelin, the substance that insulates the nerve cells and facilitates nerve cell function. Severe spinal injury damages the nerve cell and myelin insulation making it impossible for the brain to send sensory messages up and down the spine to your extremities. This is why severe spinal injury and nerve damage results in partial or complete paralysis.

The six subjects used for this trial are between the ages of 18-69 and were within one to two months from when they sustained severe spinal damage. Using historical data of severe spinal injury recovery and the International Standards for Neurological Classification of Spinal Cord Injury scale to monitor progress, the SCISTar trial was able to uncover the exciting trend of recovery. At the six and twelve-month mark, post-oligodendrocytes progenitor cell injections, each patient was evaluated to find that all six patients advanced at least one motor level of improvement. Four patients achieved two motor levels of improvement on at least one side of the body, and one patient advanced three motor levels of improvement. At the twelve-month evaluation, one patient exceeded the average upper extremity motor score by almost 60%.

“Four patients achieved two motor levels of improvement on at least one side of the body, and one patient advanced three motor levels of improvement.”

Progressing two motor levels after a severe spinal injury is a significant achievement, and even so early in the study, neurosurgeons are stunned with the results. Richard Fesslen, Professor of Neurosurgery at Rush University Medical Center Chicago, says, “I’ve been treating these kinds of patients for 30 years, and I’ve never seen anything like this before.” But how can we know these results are something big so soon? In previous studies similar to the SCISTar trials there is usually a leveling out of progress soon after the treatment, but the SCISTar patients have continued to improve. One subject went from quadriplegic to being able to throw a ball. This reclamation of function and independence is a glimmer of hope for surgeons all over the world working to return quality of life to patients who have suffered severe spinal damage.

There are some concerns about comparing this progress to the rate of recovery we find in historical data from over three thousand spinal injury victims because so many variables could skew the data. There is also the phenomena of spontaneous recovery in spinal damage patients that can be argued is present here in the results of SCISTar trials, but the consistent results of improvement across all six subjects make the presence of spontaneous recovery unlikely. These exciting results are driving Asteria to move forward with Phase 3 of the trials which involve increasing the number of cells injected to 20 million, and the FDA has approved special allowances to speed up the research process.

Asteria Biotherapeutics is a biotechnology company focused on regenerative stem cell research, and the SCISTar trials are funded, in part, by the California Institute for Regenerative Medicine.

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